A Danish clinical study showed that pregnant women taking oral fluconazole (Diflucan or generic drugs) to treat yeast infections may increase the risk of miscarriage. The FDA issued a security newsletter on April 26 saying that it is investigating the results of the study and other relevant research data, and will announce the final conclusions and recommendations after the investigation is completed.
The study was published in JAMA magazine in January this year and evaluated the effects of oral fluconazole exposure on spontaneous abortion and stillbirth in a large cohort of 1.4 million pregnant women registered in Denmark from 1997-2013. The results showed that the risk of spontaneous abortion was significantly higher in pregnant women treated with fluconazole compared with pregnant women without fluconazole and local topical treatments.
The FDA issued a safety alert in 2011, saying that the long-term oral administration of high-dose fluconazole (400 to 800 mg/d) to treat yeast infections during the early pregnancy period may increase the risk of fetal malformation/birth defects. However, the above-mentioned increased risk was not observed in single-agent low-dose fluconazole (150 mg/d) in pregnant women or pregnant women. In this Danish study, the patient’s medication regimen was mostly oral fluconazole 150 mg once or twice daily. Therefore, before the investigation is completed, the FDA recommends that pregnant women should be treated with oral fluconazole with caution.
The FDA reminds health care professionals that according to the guidelines of the US Centers for Disease Control and Prevention (CDC), pregnant women are only recommended to use topical antifungal agents for the treatment of vulvar or vaginal yeast infections. If they are refractory infections or relapses, they require more than conventional Treat longer treatment cycles.
Pregnant women or women who are actively preparing for pregnancy should communicate with healthcare providers about the possibility of alternative treatment if yeast infection occurs.
Oral fluconazole is usually used to treat vaginal, oral, and oesophageal yeast infections. It can also be used to treat cryptococcal meningitis that occurs in patients with compromised immune function and to prevent the spread of yeast infections in cancer patients with low immune function.
The original manufacturer of Flufluzole (Diflucan) is Pfizer, whose annual global sales peaked at 1.176 billion U.S. dollars in 2003. In 2015, global sales were 181 million U.S. dollars.